Kornimate/medical-research-clean huggingface dataset:
apremilast for atopic dermatitis - a pilot study in adults

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in ad to support the design of larger controlled studies.

to investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.

Eligibility criteria:
inclusion criteria: * disease severity of moderate, severe, or very severe by investigator global assessment. * disease severity must be greater than or equal to 6 on the rajka-langeland severity scoring system corresponding to moderate-severe disease. * baseline easi score must be greater than or equal to 11. a previous validation study for the easi scoring system revealed patients with moderate to very severe disease had mean easi scores ranging from 11-30. * candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies. * subjects must meet the washout requirements exclusion criteria: * history of active mycobacterial infection with any species (including mycobacterium tuberculosis) within 3 years prior to screening visit. subjects with mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification. * at least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years. * clinically significant abnormality on the chest x-ray (cxr) at screening. chest x-rays performed within 3 months prior to start of study drug are acceptable. * use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer). * any clinically significant abnormality on 12-lead ecg (electrocardiogram) at screening. * history of congenital or acquired immunodeficiency (e.g., common variable immunodeficiency \[cvid\]). * hepatitis b surface antigen positive or hepatitis b core antibody positive at screening. * history of human immunodeficiency virus (hiv) infection. * antibodies to hepatitis c at screening. * history of squamous cell carcinoma of the skin and thin melanoma. * systemic corticosteroid-dependent asthma. * active infection of any type at the time of enrollment.
an adaptive phase 2a/2b study of ly3871801 in adult participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the main purpose of this study is to evaluate the efficacy and safety of ly3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * have a diagnosis of adult-onset ra for at least 3 months prior to screening as defined by the 2010 acr/european league against rheumatism (eular) classification criteria. * have moderately-to-severely active ra at screening and baseline, defined by the presence of * ≥6 swollen joints based on 66 joint count, and * ≥6 tender joints based on 68 joint count. * have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csdmard) and either 1 biologic (bdmard), or targeted synthetic (tsdmard) treatment. exclusion criteria: * have class iv ra according to acr revised criteria * have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to * poorly controlled diabetes or hypertension * chronic kidney disease stage iiia or iiib, iv, or v * symptomatic heart failure according to new york heart association class ii, iii, or iv * myocardial infarction,unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before randomization * severe chronic pulmonary disease, for example, requiring oxygen therapy * major chronic inflammatory disease or connective tissue disease other than ra, including but not limited to * systemic lupus erythematosus * psoriatic arthritis * axial spondyloarthritis,including ankylosing spondylitis and non-radiographic axial spondyloarthritis * reactive arthritis * gout * scleroderma * polymyositis * dermatomyositis * active fibromyalgia, or * multiple sclerosis
tight achilles tendon, hyperpronation and anterior knee pains

Conditions: Anterior Knee Pain Syndrome

Summary: the purpose of the study is to investigate the prevalence of pain in the anterior part of the knee, amongst youngsters between 16 and 18 years of age. furthermore, this trial intends to study the connection between the pain, hyperpronation of the foot and tight achilles tendon. we want to find out if there is a need of an early effort in terms of information, training and/or support for the shoes.

all students (around 300) between 16 and 18 years of age from one gymnasium, receives a questionnaire. they are asked to answer whether they have had pain in the anterior part of their knee within the last month. if so they are invited to participate in a scientific study. an equivalent group with no pain are invited to participate as a control group. in both groups navicular drop and drift will be measured together with the dorsal flexion. the investigations are made single-blinded as the investigators do not know if the "patient" has pain or not.

Eligibility criteria:
inclusion criteria: * informed consent, and for those being under 18 years of age, their parents signature. * anterior knee pain syndrome and for the control group: no knee pain syndrome exclusion criteria: * former knee surgery * any form of arthritis * diagnosed meniscus or other injuries in the knee

Keywords: tight achilles tendon hyperpronation of the foot
the effect of east-west collaborative medicine on chronic cervical pain

Conditions: Chronic Neck Pain

Summary: the purpose of this study is to assess the effect of east-west collaborative medicine on chronic cervical pain.

design: this is a randomized, controlled study. participants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups. intervention: over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks

Eligibility criteria:
inclusion criteria: - presence of chronic neck pain exclusion criteria: * cancer * spinal infection * ankylosing spondylosis * myelopathy * moderate hypertension or more * serious mental disease * other skeletomuscular disease * history of operation or acupuncture treatment about spinal disease

Keywords: cervical pain neck pain western medicine oriental medicine acupuncture needle
role of k+ and ca2+ in development of muscle fatigue

Conditions: Skeletal Muscle Fatigue in Humans

Summary: the aim of the study is to investigate the role of k+ and ca2+ in development of muscle fatigue in trained young men.


Eligibility criteria:
inclusion criteria: * physical active healthy men * aged 18-40 years exclusion criteria: * smokers * allergy towards terbutaline * chronic disease
troglitazone in treating patients with liposarcoma

Conditions: Sarcoma

Summary: troglitazone may help liposarcoma cells develop into normal cells. this was a single arm, open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype.

objectives: i. to evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype. ii. to perform correlative imaging, biological, and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention. iii. to evaluate the tolerance and safety of troglitazone in this patient population. projected accrual: initially, 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued. if 1 or more patients show evidence of biological response, an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype. if 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype.

Eligibility criteria:
disease characteristics: histologically proven liposarcoma that is incurable by standard surgery measurable or evaluable disease required no active cns involvement or leptomeningeal disease patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: absolute neutrophil count at least 1500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 2.0 mg/dl sgot less than 5 times upper normal limit renal: creatinine no greater than 2.0 mg/dl cardiovascular: no poorly controlled atrial arrhythmias, angina pectoris, or myocardial infarction within past 6 months no symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within past 3 months other: not pregnant or nursing fertile patients must use effective contraception no known active retroviral disease prior concurrent therapy: recovered from toxic effects of all prior therapy no concurrent cytotoxic therapy biologic therapy: not specified chemotherapy: prior chemotherapy allowed endocrine therapy: no concurrent hormonal therapy radiotherapy: prior radiation therapy for metastatic disease allowed no radiotherapy to sole site of measurable disease within past 6 months surgery: not specified

Keywords: adult liposarcoma recurrent adult soft tissue sarcoma
use of gnrha during chemotherapy for fertility protection

Conditions: Breast Cancer Female; Acute Leukemia; Lymphoma; Osteosarcoma; Soft Tissue Sarcoma; Ewing Sarcoma

Summary: many cytotoxic drugs may harm the fertility of young women treated for cancer. the aim of the study is to investigate if the gonadotropin-releasing hormone agonist (gnrha) during cancer treatment can preserve the fertility of young female cancer subjects. approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment. the patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. the injections may be given once monthly or once three months depending on type of chemotherapy given. randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. the only person who knows is the nurse preparing the injection. patients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires.


Eligibility criteria:
inclusion criteria: * signed informed consent * breast cancer or acute leukemias, lymphomas (hodgkin and non-hodgkin) or sarcomas (osteo, soft tissue and ewing) confirmed by histology and assigned for diseace-specific chemotheraphy * confirmed menarche * ecog performance status 0-1 * adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders exclusion criteria: * demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data * previous or planned bilateral oophorectomy * pregnancy or breastfeeding at time of start of chemotherapy * other malignancy diagnosed within the last five years * uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia * known osteoporosis * known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias * known or suspected allergy against triptorelin * direct radiation of the gonads previous or planned (tbi allowed) * mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation

Keywords: fertility protection of young women receiving chemotherapy
the role of opioidergic systems in breathing based analgesia

Conditions: Pain

Summary: the purpose of this psychophysical and pharmacologic study is to determine if slow-breathing induced pain relief is mediated by endogenous opioids in response to intravenous (iv) administration of the opioid antagonist naloxone during noxious heat stimulation. we were also interested in disentangling the endogenous analgesic mechanisms supporting mindfulness-based analgesia.

the proposed study will employ a graded analytical approach to compare mindfulness to placebo-meditation and a slow-breathing exercise in response to double-blind intravenous administration (iv) of naloxone/placebo-saline and noxious heat stimulation. the aim of this study is to determine if slow-breathing induced analgesia is associated with the release of endogenous opioids. the proposed study will disentangle the specific stage of cognitive and/or respiration-based involvement (if any) of opioidergically mediated pain relief, a critical step in identifying the specific analgesic mechanisms corresponding to mindfulness based cognitive techniques.

Eligibility criteria:
inclusion criteria: * normal volunteers with no history of chronic pain problems * volunteers had no prior meditation experience * volunteers could be male and non-pregnant females. * volunteers of all ethnic backgrounds were included. exclusion criteria: * female volunteers could not be pregnant. * they could not be taking opioids or antidepressants. * subjects with a repeated history of syncope, loss of consciousness, light headedness, nausea, dizziness, or vomiting in response to needles or blood could not participate in the study. * subject could not be using exogenous opiates for the complete duration of the study.

Keywords: pain slow-breathing mindfulness opioids placebo
the effect of vitamin d on fertility

Conditions: Infertility; Infertility, Female; Vitamin D Deficiency; Vitamin D3 Deficiency

Summary: objective: to examine the effect of vitamin d supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles. design: experimental study with a pre- and post-test. setting: in vitro fertilization center patients: its sample consisted of 118 women, 58 in the experimental group and 60 in the control group. intervention(s): at the beginning of the infertility treatment, the experimental group took vitamin d supplements, and the control group did not. vitamin d supplementation for infertile women includes regulation of a diet rich in vitamin d, educational and motivational interviews about insolation, and taking vitamin d orally. main outcome measure(s): 25(oh)d and beta hcg levels


Eligibility criteria:
inclusion criteria: * 18-45 years old * literate in turkish * voluntary participation * primarily infertile * had undergone controlled ovarian hyperstimulation and had a fresh et * vitamin d levels lower than 30ng/ml before infertility treatment exclusion criteria: * patients with uncorrected congenital or acquired uterine anomalies * bone, parathyroid gland, kidney and liver disorders * use of anticonvulsants/antacid drugs * taking dietary supplements contain vitamin d * secondary infertility

Keywords: vitamin d vitamin d supplementation infertility d vitamin deficiency infertile women embryo transfer pregnancy rate
evaluation study of l-t3 utility in the follow-up of patients with thyroid cancer

Conditions: Thyroid Cancer

Summary: to compare the hypothyroid state in patients with thyroid cancer prepared either by placebo or l-t3 following l-t4 withdrawal in preparation for whole body scintigraphy. to evaluate the time needed for tsh elevation (\> 30 mui/l) on placebo vs. l-t3.

patients with well differentiated thyroid cancer (dtc) need whole-body scintigraphy (wbs) and thyroglobulin (tg) measurement in order to detect recurrence. classically, withdrawal from levothyroxine (l-t4) during 4-6 weeks is needed for tsh elevation (\> 30mui/l), to allow iodine uptake and tg production. as a result, patients become hypothyroid with impaired quality of life and a potential for tumour flare-up. recombinant htsh before wbs prevents hypothyroidism but is not yet approved for radioiodine treatment and is an expensive therapy. l-t3 substitution during the first 2-3 weeks of withdrawal is an alternative used empirically to prepare patients; however, no data exists to prove its benefit upon reducing hypothyroidism. objectives: 1) to compare the hypothyroid state in patients prepared either by placebo or l-t3 following l-t4 withdrawal. 2) to evaluate the time needed for tsh elevation (\> 30 mui/l) on placebo vs. l-t3. method: at the time of l-t4 withdrawal or after thyroidectomy, patients with dtc awaiting wbs or radioiodine treatment were randomized in two groups (double-blind): l-t3 (50 mg qd) or an identical placebo for 3 weeks, after which treatment was stopped for 2 weeks. a validated questionnaire of signs and symptoms of hypothyroidism (billewicz's scale) was administered every 2 weeks until the wbs. tsh, ft4 and ft3 were measured weekly.

Eligibility criteria:
inclusion criteria: * patients with well-differentiated thyroid cancer, with total thyroidectomy * 18 y.o. or older exclusion criteria: * use of rhtsh for whole body scintigraphy preparation * non stable cardiac arrythmias * any condition impairing tsh elevation(glucocorticoid use, hypopituitarism) * allergy to liothyronine * inability to give a consent

Keywords: thyroid cancer hypothyroidism whole body scintigraphy liothyronine tsh elevation
m-tace treatment for unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this study aims to investigate the safety and efficacy of transarterial chenmoembolization（tace） combined with microspheres for unresectable hepatocellular carcinoma(hcc).


Eligibility criteria:
inclusion criteria: 1. 18≤age\<80 on day of signing informed consent. 2. have histologically confirmed diagnosis or radiological diagnosis of hcc with at least one \>3cm targeted lesion. 3. have barcelona clinic liver cancer (bclc) stage c disease or bclc stage b disease, bclc stage a disease but refuse a surgical or ablation therapy. 4. have a child-pugh class a/b（\<7） liver score. 5. have a performance status of 0 or 1 using the ecog. 6. have a predicted life expectancy of greater than 3 months. exclusion criteria: 1. the targeted lesions have received tace or other locoregional therapy within 3 months. 2. tumor burden over 70% of the liver volume. 3. lesions can not be measured by mrecist. 4. has a diagnosed additional malignancy. 5. patients with hb\ 3mg/dl，alt/ast\>5 ul, alb\ 2.3, cr \>2mg/ml or ccr\<30ml/min. 6. severe heart, lung or cerebral disease.
oral surgery virtual reality glasses study

Conditions: Procedural Anxiety; Procedural Pain

Summary: the goal of this randomized trial is to investigate if using virtual reality (vr) glasses for patients who require non-emergent oral surgery procedures under intravenous (iv) sedation improves their overall experience compared to using standard of care safety glasses. this study has two primary objectives. 1. to evaluate if vr glasses can improve patient tolerance during iv access, sedation induction, and the surgical procedure. 2. to investigate whether the use of vr glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure. 80 subjects will be randomly assigned 1:1 to either wear vr glasses playing a relaxing video and audio or vr glasses that will only serve as eye protection (control group).


Eligibility criteria:
inclusion criteria: * patients requiring iv sedation for oral surgery procedure * patients able to understand the use of virtual reality glasses and provide informed consent/assent * patients classified as american society of anesthesiologists (asa) i or ii * no reported substance use within the previous 24 hours * no reported excessive alcohol consumption * willingness to wear eye protection * willingness to use certified interpreters if required * a legal guardian must accompany minors exclusion criteria: * patient with hearing aids or severe hearing impairment * patient with blindness or significant visual impairment that is not corrected by contact lenses * patients with cognitive impairments determined and assessed by the researchers * pregnant women or women who could be pregnant based on self reporting * patients unable to tolerate virtual reality glasses due to motion sickness or other issues * patients with history of seizures or epilepsy per self report * patients who cannot tolerate vr glasses due to discomfort or a medical emergency that arises during the procedure

Keywords: virtual reality glasses non emergent oral surgery iv sedation patient health questionnaire (phq) generalized anxiety disorder (gad)
comparison of the vasomotor function and myocardial flow in patients treated with bioresorbable and metallic stents at 1 year

Conditions: Stable Angina

Summary: background: a total of 25-50% of patients with stable coronary atherosclerosis treated with metallic stent implantation remain with effort angina despite optimal medical treatment and absence of stent restenosis at 1 year. the most plausible cause of persistent effort angina after stent implantation is microcirculatory dysfunction. coronary circulation matches the myocardial blood supply and oxygen consumption. metallic stent implantation has been related with endothelial dysfunction and impaired coronary blood flow reserve (relation between coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year. bioresorbable vascular scaffold (bvs) has been shown to improve the endothelial function and to improve the angina symptoms at 1 year. however, the coronary blood flow of bvs has never been tested. main objective: to determine differences in the blood average peak velocity at maximal hyperemia with adenosine infusion between patients treated with bioresorbable and metallic coronary stents at 1 year after stent implantation. methodology: a total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent (ees) versus everolimus-eluting bvs implantation in patients with stable coronary disease. at 1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor drugs. a pressure/doppler wire is advanced distally to the "treated segment" and the endothelial (acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor function is assessed with quantitative coronary angiography and pressure and doppler measurements. angina test questionnaires are obtained at different time-points of the study. expected results: a difference between patients treated with bvs and ees of 12.0 cm/sc in the maximal average peak velocity (apv) under maximal hyperemia (with adenosine administration) is expected, as assessed by doppler measurements, at 1 year after stent implantation. the study is powered to assess superiority in terms of maximal apv favoring patients treated with bvs.


Eligibility criteria:
inclusion criteria: * patients with stable angina or silent angina with myocardial ischemia detected by non-invasive tests or patients with acute coronary syndromes with no increase of \> 5 times the upper value of normality of cardiac biomarkers (troponin). * patients with coronary artery disease with angiographic stenosis \>

Keywords: coronary microcirculatory dysfunction coronary endothelium dysfunction